Bone Microcirculation After Extracorporeal Shock Wave Therapy

Fractured Metacarpal Bone Clinical Trial

Official title:

Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424084
• Other study ID #: 14-266-4
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: February 2023

Study information

• Verified date: February 2023
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of extracorporeal shock wave therapy on scaphoid bones and metacarpal and metatarsal in a human in-vivo setting for the first time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Group A (n=20): Consent-capable male and female patients =18 years of age who have an intact scaphoid.
• Group B (n=20): Consent-capable male and female patients =18 years of age who have an intact metacarpal bone.
• Group C (n=20): Consent-capable male and female patients =18 years of age who have a fractured scaphoid.
• Group D (n=20): Consent-capable male and female patients =18 years of age who have a fractured metacarpal bone.

Exclusion Criteria:

• below 18 years of age
• scar tissue above scaphoid or metacarpal bone
• osteoporosis or comparable bone disease
• medication that influences bones

Related Conditions & MeSH terms

• Fractured Metacarpal Bone
• Fractured Scaphoid Bone
• Fractures, Bone
• Intact Metacarpal Bone
• Intact Scaphoid Bone

Intervention

Device:
• Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Extracorporeal Shock Wave Therapy

Locations

Country	Name	City	State
Germany	University of Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microcirculation (composite outcome measure)	Bone blood flow [arbitrary units AU]; Bone blood velocity [AU]; Tissue oxygen saturation [%]; Relative postcapillary venous filling pressure [AU] (Composite outcome measure)	Baseline and 1 minute post-dose